'Validation and Development of New Dichoptic VR-gaming Method to Treat Childhood Amblyopia; Vedea Amblyopia Therapy (VAT)

Status: Active_not_recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye. The main question it aims to answer is to prove that the VAT is as effective or more effective than the current gold standard for treating children with lazy eye. This is occlusion therapy by patching the dominant eye. Participants will play VR-games specifically designed for children with lazy eye for 30 minutes per day, 5 days per week for 16 weeks. This group of children will be compared to children that undergo regular occlusion therapy to see how both treatments options compare.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 10
Healthy Volunteers: f
View:

• wearing the full corrected refraction for ≥14 weeks to adapt to the glasses

• diagnosed with an unilateral anisometropic, strabismic and/or deprivation amblyopia.

⁃ Amblyopia was defined as an intraocular difference (IOD) in visual acuity (VA) of 0.2 log MAR (2 lines) or more. Angle of strabismus ≤ 10 prism diopters at near and distance fixation. Current clear media (in case of deprivation amblyopia after successful surgery).

• currently under treatment or starting treatment for unilateral amblyopia

• participants must have easy access to an Android device equal to or higher than a Samsung Galaxy S8

• written informed consent by parents or legal guardians

Locations
Other Locations
Netherlands
Jeroen Bosch Ziekenhuis
's-hertogenbosch
The Rotterdam Eye Hospital
Rotterdam
Time Frame
Start Date: 2023-02-22
Completion Date: 2024-12-01
Participants
Target number of participants: 74
Treatments
Experimental: Vedea Amblyopia Therapy (VAT) then Vedea Amblyopia Therapy
Children in this intervention arm will use the VAT for 16 weeks.~After the initial 16 weeks of treatment these children will be allowed to use the VAT for another 16 weeks.
Active_comparator: Occlusion therapy then Vedea Amblyopia Therapy (VAT)
Children in this intervention arm will adhere to a 'care as usual' regimen consisting of occlusion therapy as prescribed by their health care provider. They will do so for 16 weeks.~After the initial 16 weeks of treatment these children will crossover into the experimental arm to examine if they are still responsive to the VAT after already completing 16 weeks of traditional treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Elisabeth-TweeSteden Ziekenhuis, Oogziekenhuis Rotterdam, Rotterdams Oogheelkundig Instituut, Health Holland, Jeroen Bosch Ziekenhuis
Leads: Vedea Healthware BV

This content was sourced from clinicaltrials.gov